Volver a Agenda
Session 2: Regulatory Updates on Polices and New Guidances from Other Territories and International Harmonization
Session Chair(s)
Mamiko Kasho
Executive Director, Global PV Management Dept., Global Safety HQs, Eisai Co., Ltd., Japan
The session will provide updates on pharmacovigilance and risk management in countries of Asia region and how we comply with local specific requirements in those rapidly evolving environments. The focus this year will be describing pharmacovigilance requirements in India, some updates in China and Japan, and comparison of Pharmacovigilance System Master File requirements in Asia.
Learning Objective : - Describe the regulatory requirements for drug safety in the Middle East and African countries and key challenges
- Recognize the high-level overview of TransCelerate PV initiatives update and global harmonization activities
Speaker(s)
Mamiko Kasho
Executive Director, Global PV Management Dept., Global Safety HQs, Eisai Co., Ltd., Japan
PV Overview of Egypt
Representative Invited
Head of central administration of Pharmaceutical Care, Egyptian Drug Authority (EDA), Egypt
Andrew Bate, PHD, MA
Vice President, Head of Safety Innovation and Analytics, GSK, United Kingdom
Zakaria Thamri, PHARMD
Regional Patient Safety Lead - India, Middle East, Turkey and Africa, Boehringer Ingelheim, United Arab Emirates
¿Tiene una cuenta?